Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

Phase 4 Unknown 152 enrolled University Hospital, Antwerp Erasme University Hospital · collab Novartis Pharmaceuticals · collab Universitair Ziekenhuis Brussel · collab University Hospital, Ghent · collab University of Liege · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events. The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Timeline

Start: 2008-10
Primary completion: 2010-04
Completion: 2015-04

Publications

Pipeleers L, Abramowicz D, Broeders N, Lemoine A, Peeters P, Van Laecke S, Weekers LE, Sennesael J, Wissing KM, Geers C, Bosmans JL. 5-Year outcomes of the prospective and randomized CISTCERT study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients. Transpl Int. 2021 Feb;34(2):313-326. doi: 10.1111/tri.13798. Epub 2020 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	4 mg/kg	Oral
Comparator	Everolimus	Small molecule	0.75 mg	—

Indications

No indication recorded.